title: A suggested approach for implementing CONSORT guidelines specific to obstetric research.
abstract: The conduct and reporting of randomized controlled trials (RCTs) are enhanced by being compliant with the CONsolidated Standards of Reporting Trials (CONSORT) statement. The statement was meant to be general and was aimed at most RCTs without any particular focus on specific groups of patients. However, research in pregnancy presents important unique issues and challenges that are not addressed in the CONSORT statement. Thus, we suggest that there is a need to amend the statement to address RCTs enrolling pregnant or postpartum women. We propose CONSORT-OB (OBstetrics), with more than 30 modifications to the current statement. We hope the CONSORT group would consider our proposal, and we respectfully suggest that investigators incorporate these additional data into their reporting of RCTs involving pregnant or postpartum women.
authors.affiliation: Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia; and the Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, UT Health-University of Texas Medical School at Houston, Houston, and the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.
authors.forename: Suneet P
authors.initials: SP
authors.lastname: Chauhan
authors.forename: Sean C
authors.initials: SC
authors.lastname: Blackwell
authors.forename: George R
authors.initials: GR
authors.lastname: Saade
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D005260:Female; D006284:Health Plan Implementation; D006801:Humans; D009774:Obstetrics / Q000592:standards*; D049590:Postpartum Period; D017410:Practice Guidelines as Topic / Q000592:standards*; D011247:Pregnancy; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*